Use caution Medical device recall · FDA · Published April 25, 2018

Intersurgical Flexible Smoothbore Breathing Circuit Recall: Exhalation Port Blockage Risk

Intersurgical recalls flexible breathing circuits with exhalation port 22mm due to risk of blocking during assembly, potentially causing serious patient health issues. Affected units include specific product numbers listed in the recall.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2302-2018Medical device Intersurgical ›

Use caution until it’s fixed

When assembling an HME or Filter on this breathing circuit the tubing may be pushed up and inadvertently cover or block the exhalation port. This could potentially pose a serious health risk to the patient.

Take action

Contact the company

Recalling firmIntersurgical Inc6757 Kinne St. · E. Syracuse, NY 13057

✎ GovInfoNow plain-language explainer

Intersurgical is recalling flexible breathing circuits with exhalation ports that may block during assembly, which could cause serious health risks for patients. This recall affects specific product models sold in the U.S. and requires users to check their units against the listed serial numbers. Read more at govinfonow.com/recall/71333-intersurgical-flexible-smoothbore-breathing-circuit-recall-exhalation-port-blockage-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/71333-intersurgical-flexible-smoothbore-breathing-circuit-recall-exhalation-port-blockage-risk · Updated August 21, 2026 · FDA enforcement record: FDA #Z-2302-2018

Cite this page

“Intersurgical Flexible Smoothbore Breathing Circuit Recall: Exhalation Port Blockage Risk.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71333-intersurgical-flexible-smoothbore-breathing-circuit-recall-exhalation-port-blockage-risk. Based on FDA recall #Z-2302-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2302-2018%22&limit=1).

The FDA announced on April 25, 2018, that Intersurgical Inc voluntarily recalled its Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm due to a potential blockage hazard. The agency stated the recall affects 1,340 units distributed in Illinois, New Jersey, Nevada, Texas, and Utah.

How to tell if you have it

Brand: Intersurgical
Product: Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm
Product No.: 80062000
Lot codes: 0261604, 0671602, 0671603, 0741609, 0751601, 0821605, 0821606, 0891605, 0891606, 0951609, 0961601, 1751601, 0011802, 0011803, 0021803, 0081808 and 0161805

The hazard

According to the FDA, assembling an HME or Filter on this breathing circuit may push the tubing up and inadvertently cover or block the exhalation port. The agency noted this could potentially pose a serious health risk to the patient.

Context

GovInfoNow's records show Intersurgical Inc has issued six other recalls since August 7, 2019. Recent similar product recalls include Hamilton Medical Breathing Circuit Sets Risk: Exhalation Obstruction During Ventilation (May 29, 2026) and ConMed AirSeal 5mm Port Recall: Overpressure Alert Risk (May 14, 2026).

How to tell if you have this one

Check the product serial numbers listed: 0261604, 0671602, 0671603, 0741609, 0751601, 0821605, 0821606, 0891605, 0891606, 0951609, 0961601, 1751601, 0011802, 0011803, 0021803, 0081808, and 0161805.

Brand
Intersurgical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Serial Numbers
Compare your unit's serial number with the list provided in the recall to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed in 5 states.

FDA distribution: “Distributors in IL, NJ, NV, TX, UT.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Illinois, Nevada, New Jersey, Texas, Utah.

Recall timeline

FDA terminated this recall 11 months after the firm started it.

Apr 25, 2018Firm started the recall
Jun 27, 2018FDA classified it Class II
Jul 4, 2018Published in FDA’s Enforcement Report
Apr 9, 2019FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/71333-intersurgical-flexible-smoothbore-breathing-circuit-recall-exhalation-port-blockage-risk">Intersurgical Flexible Smoothbore Breathing Circuit Recall: Exhalation Port Blockage Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2302-2018 (April 25, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2302-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.